Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on March 26, 2024 and September 23, 2025 are noted. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 63, 69-71, 97, 99-100, and 103 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
With respect to claim 63, the claim limitation of “the one or more injectable bone inducing agents are predisposed within the porous structure” are unclear. It is noted that the applicant is claiming an implant with an open portion that is “configured to receive one or more injectable bone inducing agents”. Therefore, it is noted that the bone inducing agents are NOT claimed. Therefore, since the applicant is not claiming the bone inducing agents, the limitation of claim 63 are unclear as to how they are ”predisposed”. It is noted that for examination purposes, the limitation is being interpreted as they can be predisposed before implantation and also in the alternative that they are predisposed, however, the applicant should amend the claim to clarify what is being claimed. Specifically if the applicant wants to require the bone inducing agents, the applicant should make it clear that they are injected before implantation and not necessary impregnated in the porous sturcutre in order to avoid new matter issues.
The same issue applies to claim 69 and are being interpreted the same as above.
Further the limitations of claim 100 are further unclear as to if the one or more injectable bone inducing agents are the same as those of the independent claim. It is noted that for examination purposes, the limitation is being interpreted as being the same as those of the independent claim, however, the applicant should amend the claim to clarify what is being claimed.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 28, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Han et al. (2018/0344435) in view of Russell et al. (2011/0060373).
Han teaches with respect to claim 1, a threaded implant 100 comprising an implant body having an external thread 109 on an external surface of the implant body (see figs. 2-3), the implant body comprising an upper portion 102 with an open ceiling 107 configured to receive one or more injectable bone inducing agents (par. 39), a middle portion 13 defining a hollow inner channel 110 (par. 16), and a lower portion 104 with a closed floor 108, wherein the hollow inner channel extends from the open celling to the closed floor (see fig. 3, pars. 17-19), wherein the middle portion defines one or more side openings 106 extending from the hollow inner channel (see fig. 6, par. 47) rotating in a helix-like shape in a same direction as that of a plurality of turns of the external thread (see figs. 1-2, such that they both rotate in a right to left direction), wherein dimensions of the side openings are of sizes designed to enable bone and bone tissue ingrowth into the hollow inner channel and bone and bone tissue outgrowth from the hollow inner channel to the surrounding bone (par. 51). Han teaches the invention as substantially claimed and discussed above, however, does not specifically teach wherein a porous structure is disposed within the hollow inner channel, the porous structure defining a plurality of pores, wherein at least one of the plurality of pores is in fluid communication with at least one of the one or more side openings.
Russell teaches a threaded implant (see fig. 4c) comprising an implant body having an external thread on an external surface of the implant body, the implant body comprising an upper portion with an open ceiling configured to receive one or more injectable bone inducing agents, a middle portion defining a hollow inner channel, and a lower portion with a closed floor, wherein the hollow inner channel extends from the open ceiling to the closed floor, wherein the middle portion defines one or more side openings 5 extending from the hollow inner channel and further with respect to claim 2, teach a porous structure 12 is disposed within the hollow inner channel, the porous structure defining a plurality of pores, wherein at least one of the plurality of pores is in fluid communication with the at least one of the one or more side openings (par. 99). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Han with the porous structure in the cavity as taught by Russell in order to vary the amount of the flowable material to the openings.
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With respect to claim 28, Han/Russell teaches the invention as substantially claimed and discussed above, Han further teaches the threaded implant further comprising a plug-in screw, a healing cap screw, or an abutment screw removably couplable with the open ceiling, extending into the hollow inner channel (pars. 27, 50, claim 5).
With respect to claim 30, Han/Russell teaches the invention as substantially claimed and discussed above, Han further teaches the threaded implant wherein the lower portion comprises one or more self-tapping cuts at a front end of the lower portion (par. 49).
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Han et al. (2018/0344435) in view of Russell et al. (2011/0060373) as applied to claim 28 above, and further in view of Stucki-McCormick (2003/0165795).
Han/Russell teaches the invention as substantially claimed and discussed above, however, does not specifically teach wherein the plug-in screw, the healing cap screw, the abutment screw, or any combination thereof define one or more features for engaging a removal instrument.
Stucki-McCormick teaches a threaded implant comprising an implant body having an external thread on an external surface of the implant body, the implant body comprising an upper portion with an open ceiling, the implant further comprising an abutment screw 100 removably couplable with the open ceiling and wherein the abutment screw defines a feature 96 for engaging a removal instrument (see figs. 7-8c, par. 89). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the plug-in screw, healing cap screw, or abutment screw of Han/Russell to include a feature for engaging a removal instrument in order to allow for easy attachment and removal of the elements during the procedure.
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Han et al. (2018/0344435) in view of Russell et al. (2011/0060373) as applied to claim 1 above, and further in view of U.R.Anoop et al. (2017/0028127).
Han/Russell teaches the invention as substantially claimed and discussed above, however, does not specifically teach the hollow inner channel tapers from a largest diameter closest to the open ceiling to a smallest diameter adjacent the closed floor.
U.R.Anoop teaches threaded implant (see fig. 2) comprising an implant body having an external thread on an external surface of the implant body (see fig. 2), the implant body comprising an upper portion with an open ceiling configured to receive one or more injectable bone inducing agents (see fig. 2, such that the upper end of the implant received element 206 which injects a material into the implant), a middle portion defining a hollow inner channel (see fig. 2, such that portion with openings 210 is received within the hollow inner channel), and a lower portion (see fig. 2, such that the lower portion is the tip of the implant), wherein the hollow inner channel extends from the open ceiling to the closed floor (see fig. 2) wherein the middle portion defines one or more side openings 201 extending from the hollow inner channel (see fig. 2). U.R.Anoop further teaches with respect to claim 34, the hollow inner channel tapers from a largest diameter closest to the open ceiling to a smallest diameter adjacent the floor (see fig. 2). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Han/Russell with the tapered hollow inner chamber in order to assist in the flow of the material, such that the tapered shape helps the fluid flow towards the tip. It is further noted that U.R.Anoop teaches a cylindrical inner chamber as taught by Han, therefore, U.R.Anoop teaches that the two different shape are known equivalents.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Han et al. (2018/0344435) in view of Dosta et al. (2009/0208907) in view of Chang (WO 2019/240478).
Han teaches with respect to claim 1, a threaded implant 100 comprising an implant body having an external thread 109 on an external surface of the implant body (see figs. 2-3), the implant body comprising an upper portion 102 with an open ceiling 107 configured to receive one or more injectable bone inducing agents (par. 39), a middle portion 13 defining a hollow inner channel 110 (par. 16), and a lower portion 104 with a closed floor 108, wherein the hollow inner channel extends from the open celling to the closed floor (see fig. 3, pars. 17-19), wherein the middle portion defines one or more side openings 106 extending from the hollow inner channel (see fig. 6, par. 47) rotating in a helix-like shape in a same direction as that of a plurality of turns of the external thread (see figs. 1-2, such that they both rotate in a right to left direction), wherein dimensions of the side openings are of sizes designed to enable bone and bone tissue ingrowth into the hollow inner channel and bone and bone tissue outgrowth from the hollow inner channel to the surrounding bone (par. 51). Han teaches the invention as substantially claimed and discussed above, however, does not specifically teach wherein a porous structure is disposed within the hollow inner channel, the porous structure defining a plurality of pores, wherein at least one of the plurality of pores is in fluid communication with at least one of the one or more side openings.
Dosta teaches a threaded implant comprising an implant body 12 having an external thread 13 on an external surface of the implant body, the implant body comprising an upper portion with an open ceiling 17 configured to receive one or more injectable bone inducing agents (see abstract, such that the medicinal preparations are capable of being a bone inducing agent), a middle portion defining a hollow inner channel (see fig. 4, the channel being occupied by the porous insert 15) and a lower portion (the end of the implant), wherein the hollow inner channel extends from the opening ceiling to the lower portion, wherein the middle portion defines one or more side openings 14 extending from the hollow inner channel, wherein dimensions of the one or more side openings are of sizes designed to enable bone and bone tissue ingrowth into the hollow inner channel and bone and bone tissue outgrowth form the hollow inner channel to the surround bone (par. 25, 35-36, abstract), wherein a porous structure 15 is disposed within the hollow inner channel, the porous structure defining a plurality of pores, wherein at least one of the plurality of pores is in fluid communication with at least one of the one or more side openings (see figs. 3-4, pars. 25, 31, 34). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Han with the porous structure taught by Dosta in order to provide the implant with a reliable fixation of the implant in the osseous tissue due to a more complete fusion of the osseous tissue with the porous inner implant area (see par. 6 of Dosta).
With respect to claim 2, Han/Dosta teaches the invention as substantially claimed and discussed above, however, does not specifically teach the porous structure is biodegradable in vivo.
Chang teaches a threaded implant comprising an implant body 6 having an external thread 7 on an external surface of the implant body, the implant body comprising a middle portion defining a hollow inner channel (occupied by element 100), wherein the middle portion defines one or more side openings 9 extending from the hollow inner channel, wherein dimensions of the one or more side openings are of sizes designed to enable bone and bone tissue ingrowth into the hollow inner channel and bone and bone tissue outgrowth form the hollow inner channel to the surrounding bone (par. 62), wherein a structure 100 is disposed within the hollow inner channel. Chang further teaches with respect to claim 2, wherein the structure is biodegradable (pars. 27, 50, 57). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the porous member taught by Han/Dosta to be biodegradable as taught by Chang in order to maximize osseointegration area between the fixture and bone (par. 1, 15 of translation).
Claim(s) 35, 62-65 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim (2015/0230889) in view of Dosta et al. (2009/0208907).
Kim teaches with respect to claim 35, threaded implant 100 comprising an implant body having an external thread 109 on an external surface of the implant body, the implant body comprising an upper portion 102 defining an open ceiling 107 configured to receive one or more injectable bone inducing agents (see abstract), a middle portion 103 defining a hollow inner channel 110 (par. 36), and a lower portion 104 with a closed floor 108 (par. 35), wherein the hollow inner channel extends from the open ceiling to the closed floor (abstract, par. 36, fig. 2e, 4) wherein the middle portion defines one or more side openings 106 extending from the hollow inner channel (par 36), rotating in a helix-like shape (par. 6, figs. 2d, 3b, 4), wherein dimensions of the side openings are of sizes designed to enable bone and bone tissue ingrowth into the hollow inner channel and bone and bone tissue outgrowth from the hollow inner channel to the surrounding bone (see abstract, par. 15). Kim teaches the invention as substantially claimed and discussed above, however, does not specifically teach a porous structure is separately formed and removably disposed within the hollow inner channel of the implant body, the porous structure defining a plurality of pores, wherein at least one of the plurality of pores is in fluid communication with at least one of the one or more side openings.
Dosta teaches a threaded implant comprising an implant body 12 having an external thread 13 on an external surface of the implant body, the implant body comprising an upper portion with an open ceiling 17 configured to receive one or more injectable bone inducing agents (see abstract, such that the medicinal preparations are capable of being a bone inducing agent), a middle portion defining a hollow inner channel (see fig. 4, the channel being occupied by the porous insert 15) and a lower portion (the end of the implant), wherein the hollow inner channel extends from the opening ceiling to the lower portion, wherein the middle portion defines one or more side openings 14 extending from the hollow inner channel, wherein dimensions of the one or more side openings are of sizes designed to enable bone and bone tissue ingrowth into the hollow inner channel and bone and bone tissue outgrowth form the hollow inner channel to the surround bone (par. 25, 35-36, abstract), wherein a porous structure 15 is separately formed and disposed within the hollow inner channel, the porous structure defining a plurality of pores, wherein at least one of the plurality of pores is in fluid communication with at least one of the one or more side openings (see figs. 3-4, pars. 25, 31, 34, such that par. 25 teaches the two elements being formed separately and par. 33 teaches the porous structure positioned inside the channel). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Kim with the porous structure taught by Dosta in order to provide the implant with a reliable fixation of the implant in the osseous tissue due to a more complete fusion of the osseous tissue with the porous inner implant area (see par. 6 of Dosta). It is noted that Dosta does not specifically teach the porous structure is removeably disposed within the hollow inner channel but does teach as discussed above that it is made separately and inserted into the bore. Therefore, it is noted that since it is a separate element and inserted into the bore, it would be removable as claimed. It is noted that the limitation of being removably disposed is functional and therefore, it the apparatus taught by the prior art is capable of functioning as claimed, then the claimed limitations are met. Since, as discussed above in detail, the prior art of Dosta teaches the porous structure being made separately and inserted into the channel, the device is capable of functioning as claimed and therefore, the claimed limitations are met by the prior art. It is further noted that the applicant does not teach an advantage or unexpected result by making the porous structure removable and further teaches both an integral embodiment and the claimed separate parts as an alternative embodiment. Further it is noted that it has been held to be within the general skill of a worker the art to make elements separable (see MPEP 2144.04, V, C).
With respect to claim 62, Kim/Dosta teaches the invention as substantially claimed and disclosed above, Kim further teaches the threaded implant further comprising a plug-in screw, a healing cap screw, or an abutment screw removably couplable with the open ceiling, extending into the hollow inner channel (pars. 44, claim 5).
With respect to claim 63, Kim/Dosta teaches the invention as substantially claimed and disclosed above and further wherein the device is capable of allowing injectable bone inducing agents to be predisposed within the porous structure (see 112 rejection above regarding the functionality of this limitation). Such that as user would be able to dispose bone inducing agents within the porous portion before implanting it.
With respect to claim 64, Kim/Dosta teaches the invention as substantially claimed and disclosed above Kim further teaches the threaded implant wherein the lower portion comprises one or more self-tapping cuts at a front end of the lower portion (par. 17).
With respect to claim 65, Kim/Dosta teaches the invention as substantially claimed and disclosed above, Kim further teaches wherein the one or more side openings rotate in a helix-like shape in an opposite direction as that of a plurality of turns of the external thread (see fig. 1).
Claim(s) 63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim (2015/0230889) in view of Dosta et al. (2009/0208907) as applied to claim 63 above, further in view of Lee (KR 20130042441).
With respect to claim 63, Kim/Dosta teaches the invention as substantially claimed and discussed above, however, does not specifically the bone inducing agent is predisposed within the porous structure.
Lee teaches an implant having a porous structure defining a plurality of pores and wherein bone inducing agents are predisposed within the porous structure (see par. 24). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Kim/Dosta to include bone inducing agents within the porous structure as taught by Lee in order to promote bone formation.
Claim(s) 68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim (2015/0230889) in view of Dosta et al. (2009/0208907) as applied to claim 35 above, and further in view of U.R.Anoop et al. (2017/0028127).
Kim/Dosta teaches the invention as substantially claimed and discussed above, however, does not specifically teach the hollow inner channel tapers from a largest diameter closest to the open ceiling to a smallest diameter adjacent the closed floor.
U.R.Anoop teaches threaded implant (see fig. 2)comprising an implant body having an external thread on an external surface of the implant body (see fig. 2), the implant body comprising an upper portion with an open ceiling configured to receive one or more injectable bone inducing agents (see fig. 2, such that the upper end of the implant received element 206 which injects a material into the implant), a middle portion defining a hollow inner channel (see fig. 2, such that portion with openings 210 is received within the hollow inner channel), and a lower portion (see fig. 2, such that the lower portion is the tip of the implant), wherein the hollow inner channel extends from the open ceiling to the closed floor (see fig. 2) wherein the middle portion defines one or more side openings 201 extending from the hollow inner channel (see fig. 2). U.R.Anoop further teaches with respect to claim 68, the hollow inner channel tapers from a largest diameter closest to the open ceiling to a smallest diameter adjacent the floor (see fig. 2). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Kim/Dosta with the tapered hollow inner chamber in order to assist in the flow of the material, such that the tapered shape helps the fluid flow towards the tip. It is further noted that U.R.Anoop teaches a cylindrical inner chamber as taught by Kim/Dosta, therefore, U.R.Anoop teaches that the two different shape are known equivalents.
Claim(s) 35-36, 62-64 is/are rejected under 35 U.S.C. 103 as being unpatentable over Han et al. (2018/0344435) in view of in view of Dosta et al. (2009/0208907).
Han teaches with respect to claim 35, a threaded implant 100 comprising an implant body having an external thread 109 on an external surface of the implant body (see figs. 2-3), the implant body comprising an upper portion 102 with an open ceiling 107 configured to receive one or more injectable bone inducing agents (par. 39), a middle portion 13 defining a hollow inner channel 110 (par. 16), and a lower portion 104 with a closed floor 108, wherein the hollow inner channel extends from the open celling to the closed floor (see fig. 3, pars. 17-19), wherein the middle portion defines one or more side openings 106 extending from the hollow inner channel (see fig. 3, par. 47) rotating in a helix-like shape (see figs. 1-2, such that they both rotate in a right to left direction), wherein dimensions of the side openings are of sizes designed to enable bone and bone tissue ingrowth into the hollow inner channel and bone and bone tissue outgrowth from the hollow inner channel to the surrounding bone (par. 20). Han teaches the invention as substantially claimed and discussed above, however, does not specifically teach a porous structure is disposed within the hollow inner channel, the porous structure defining a plurality of pores, wherein at least one of the plurality of pores is in fluid communication with the at least one of the one or more side openings.
Dosta teaches a threaded implant comprising an implant body 12 having an external thread 13 on an external surface of the implant body, the implant body comprising an upper portion with an open ceiling 17 configured to receive one or more injectable bone inducing agents (see abstract, such that the medicinal preparations are capable of being a bone inducing agent), a middle portion defining a hollow inner channel (see fig. 4, the channel being occupied by the porous insert 15) and a lower portion (the end of the implant), wherein the hollow inner channel extends from the opening ceiling to the lower portion, wherein the middle portion defines one or more side openings 14 extending from the hollow inner channel, wherein dimensions of the one or more side openings are of sizes designed to enable bone and bone tissue ingrowth into the hollow inner channel and bone and bone tissue outgrowth form the hollow inner channel to the surround bone (par. 25, 35-36, abstract), wherein a porous structure 15 is separately formed and disposed within the hollow inner channel, the porous structure defining a plurality of pores, wherein at least one of the plurality of pores is in fluid communication with at least one of the one or more side openings (see figs. 3-4, pars. 25, 31, 34, such that par. 25 teaches the two elements being formed separately and par. 33 teaches the porous structure positioned inside the channel). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Kim with the porous structure taught by Dosta in order to provide the implant with a reliable fixation of the implant in the osseous tissue due to a more complete fusion of the osseous tissue with the porous inner implant area (see par. 6 of Dosta). It is noted that Dosta does not specifically teach the porous structure is removeably disposed within the hollow inner channel but does teach as discussed above that it is made separately and inserted into the bore. Therefore, it is noted that since it is a separate element and inserted into the bore, it would be removable as claimed. It is noted that the limitation of being removably disposed is functional and therefore, it the apparatus taught by the prior art is capable of functioning as claimed, then the claimed limitations are met. Since, as discussed above in detail, the prior art of Dosta teaches the porous structure being made separately and inserted into the channel, the device is capable of functioning as claimed and therefore, the claimed limitations are met by the prior art. It is further noted that the applicant does not teach an advantage or unexpected result by making the porous structure removable and further teaches both an integral embodiment and the claimed separate parts as an alternative embodiment. Further it is noted that it has been held to be within the general skill of a worker the art to make elements separable (see MPEP 2144.04, V, C).
With respect to claim 36, Han/Dosta teaches the invention as substantially claimed and discussed above, Han further teaches wherein the one or more side openings rotate in the helix like shape in a same direction as that of a plurality of turns of the external thread (see figs. 1-3).
With respect to claim 62, Han/Dosta teaches the invention as substantially claimed and discussed above, Han further teaches the threaded implant further comprising a plug-in screw, a healing cap screw, or an abutment screw removably couplable with the open ceiling, extending into the hollow inner channel (pars. 27, 50, claim 5).
With respect to claim 63, Han/Dosta teaches the invention as substantially claimed and disclosed above and further wherein the device is capable of allowing injectable bone inducing agents to be predisposed within the porous structure (see 112 rejection above regarding the functionality of this limitation). Such that as user would be able to dispose bone inducing agents within the porous portion before implanting it.
With respect to claim 64, Han/Dosa teaches the invention as substantially claimed and discussed above, Han further discloses the threaded implant wherein the lower portion comprises one or more self-tapping cuts at a front end of the lower portion (par. 49).
Claim(s) 63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Han et al. (2018/0344435) in view of Dosta et al. (2009/0208907) as applied to claim 63 above, further in view of Lee (KR 20130042441).
With respect to claim 63, Han/Dosta teaches the invention as substantially claimed and discussed above, however, does not specifically the bone inducing agent is predisposed within the porous structure.
Lee teaches an implant having a porous structure defining a plurality of pores and wherein bone inducing agents are predisposed within the porous structure (see par. 24). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Han/Dosta to include bone inducing agents within the porous structure as taught by Lee in order to promote bone formation.
Claim(s) 68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Han et al. (2018/0344435) in view of Dosta et al. (2009/0208907) as applied to claim 35 above, and further in view of U.R.Anoop et al. (2017/0028127).
Han/Dosta teaches the invention as substantially claimed and discussed above, however, does not specifically teach the hollow inner channel tapers from a largest diameter closest to the open ceiling to a smallest diameter adjacent the closed floor.
U.R.Anoop teaches threaded implant (see fig. 2)comprising an implant body having an external thread on an external surface of the implant body (see fig. 2), the implant body comprising an upper portion with an open ceiling configured to receive one or more injectable bone inducing agents (see fig. 2, such that the upper end of the implant received element 206 which injects a material into the implant), a middle portion defining a hollow inner channel (see fig. 2, such that portion with openings 210 is received within the hollow inner channel), and a lower portion (see fig. 2, such that the lower portion is the tip of the implant), wherein the hollow inner channel extends from the open ceiling to the closed floor (see fig. 2) wherein the middle portion defines one or more side openings 201 extending from the hollow inner channel (see fig. 2). U.R.Anoop further teaches with respect to claim 68, the hollow inner channel tapers from a largest diameter closest to the open ceiling to a smallest diameter adjacent the floor (see fig. 2). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Han/Dosta with the tapered hollow inner chamber in order to assist in the flow of the material, such that the tapered shape helps the fluid flow towards the tip. It is further noted that U.R.Anoop teaches a cylindrical inner chamber as taught by Han/Dosta, therefore, U.R.Anoop teaches that the two different shape are known equivalents.
Claim(s) 69, 71, 97, 99-100 and 103 is/are rejected under 35 U.S.C. 103 as being unpatentable over Caterini (WO 01/05325) in view of Han et al. (2018/034435) in view of Lee (KR 20130042441).
Caterini teaches with respect to claim 69 a threaded implant comprising an implant body having an external thread on an external surface of the implant body (see fig. 3), the implant body comprising an upper portion defining an open ceiling and terminating at a divider (see fig. 3, such that the opening ceiling is 9 and the divider is between 9 and 16), a middle portion defining a hollow inner channel 16, and a lower portion with an open ending tip configured to receive one or more injectable one inducing agents (see fig. 3, such that the end near 7 is open and capable of functioning as claimed), wherein the hollow inner channel extends form the divider to the open ending tip (see fig. 3), wherein the middle portion defines one or more side openings 6 extending from the hollow inner channel (pg. 5, par. 6 starting “The dental implant 2 will”, see fig. 6a), wherein dimensions of the one or more side openings are of sizes designed to enable bone and bone tissue ingrowth into the hollow inner channel and bone and bone tissue outgrowth from the hollow inner channel to the surrounding bone (pg. 5, par. 6 starting “The dental implant 2 will”, see fig. 6a), wherein a porous structure 17 defining a plurality of pores is separably formed and disposed within the hollow inner channel (pg. 5, 3rd paragraph “a porous core of substantially cylindrical shape 17 is inserted”, 4th paragraph “After being fitted into the lower hole16”, which teaches the inserted is formed separately since it is inserted), wherein at least one of the plurality of pores is in fluid communication with at least one of the one or more side openings (see fig. 6a). Caterini teaches the invention as substantially claimed and discussed above, however, does not specifically teach the one or more side openings are helix-like shape and the bone inducing agent is predisposed within the porous structure.
Han teaches a threaded implant 100 comprising an implant body having an external thread 109 on an external surface of the implant body (see figs. 2-3), the implant body comprising an upper portion 102 with an open ceiling 107, a middle portion 103 defining a hollow inner channel 110 (par. 16), and a lower portion, wherein the middle portion defines one or more side openings 106 extending from the hollow inner channel (see fig. 3, par. 47) rotating in a helix-like shape (see figs. 1-2, such that they both rotate in a right to left direction), wherein dimensions of the side openings are of sizes designed to enable bone and bone tissue ingrowth into the hollow inner channel and bone and bone tissue outgrowth from the hollow inner channel to the surrounding bone (par. 51). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the shape of the openings taught by Caterini with the helix like shape of Han in order to allow for the desired bone ingrowth. It is noted that Caterini teaches the openings can be a variety of shapes including radial (see pg. 6, last full paragraph). Therefore the shape of the openings is taught as a design choice. Caterini/Han teaches the invention as substantially claimed and discussed above, however, does not specifically the bone inducing agent is predisposed within the porous structure.
Lee teaches an implant having a porous structure defining a plurality of pores and wherein bone inducing agents are predisposed within the porous structure (see par. 24). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Caterini/Han to include bone inducing agents within the porous structure as taught by Lee in order to promote bone formation.
With respect to claim 71, Caterini/Han/Lee teaches the invention as substantially claimed and discussed above, Han further teaches wherein the one or more side openings rotate in a helix-like shape in a same direction as that of a plurality of turns of the external thread (see figs. 1-3). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the shape of the openings taught by Caterini with the helix like shape of Han in order to allow for the desired bone ingrowth. It is noted that Caterini teaches the openings can be a variety of shapes including radial (see pg. 6, last full paragraph). Therefore the shape of the openings is taught as a design choice.
With respect to claim 97 Caterini/Han/Lee teaches the invention as substantially claimed and discussed above, Caterini further teaches an abutment 3, however, does not specifically teach the abutment is a screw. Han further teaches wherein the threaded implant further comprising a plug-in screw, a healing cap screw, or an abutment screw removably couplable with the open ceiling, extending into the hollow inner channel (par. 64, claim 5). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the abutment of Caterini with the threaded abutment as taught by Han in order to easily attach and remove the abutment as needed.
With respect to claim 99, Caterini/Han/Lee teaches the invention as substantially claimed and discussed above, Han further teaches the threaded implant wherein the lower portion comprises one or more self-tapping cuts at a front end of the lower portion (pars. 49, 65). It would have been obvious to one having ordinary skill in the art to modify the implant of Caterini to include self-tapping threads as taught by Han in order to easily install the implant such that the threads do not need to be tapped in an additional step.
With respect to claim 100, Caterini/Han/Lee teaches the invention as substantially claimed and discussed above, Lee further teaches wherein the one or more injectable bone inducing agents include bone morphogenetic proteins (see par. 27). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Caterini/Han to include bone inducing agents within the porous structure as taught by Lee in order to promote bone formation.
Claim(s) 69, 97, 99-100 and 103 is/are rejected under 35 U.S.C. 103 as being unpatentable over Caterini (WO 01/05325) in view of Kim (2015/0230889) in view of Lee (KR 20130042441).
Caterini teaches with respect to claim 69 a threaded implant comprising an implant body having an external thread on an external surface of the implant body (see fig. 3), the implant body comprising an upper portion defining an open ceiling and terminating at a divider (see fig. 3, such that the opening ceiling is 9 and the divider is between 9 and 16), a middle portion defining a hollow inner channel 16, and a lower portion with an open ending tip configured to receive one or more injectable one inducing agents (see fig. 3, such that the end near 7 is open and capable of functioning as claimed), wherein the hollow inner channel extends form the divider to the open ending tip (see fig. 3), wherein the middle portion defines one or more side openings 6 extending from the hollow inner channel (pg. 5, par. 6 starting “The dental implant 2 will”, see fig. 6a), wherein dimensions of the one or more side openings are of sizes designed to enable bone and bone tissue ingrowth into the hollow inner channel and bone and bone tissue outgrowth from the hollow inner channel to the surrounding bone (pg. 5, par. 6 starting “The dental implant 2 will”, see fig. 6a), wherein a porous structure 17 defining a plurality of pores is separably formed and disposed within the hollow inner channel (pg. 5, 3rd paragraph “a porous core of substantially cylindrical shape 17 is inserted”, 4th paragraph “After being fitted into the lower hole16”, which teaches the inserted is formed separately since it is inserted), wherein at least one of the plurality of pores is in fluid communication with at least one of the one or more side openings (see fig. 6a). Caterini teaches the invention as substantially claimed and discussed above, however, does not specifically teach the one or more side openings are helix-like shape and the bone inducing agent is predisposed within the porous structure.
Kim teaches threaded implant 100 comprising an implant body having an external thread 109 on an external surface of the implant body, the implant body comprising an upper portion 102 defining an open ceiling, a middle portion 103 defining a hollow inner channel 110 (par. 14), and a lower portion 104, wherein the middle portion defines one or more side openings 106 extending from the hollow inner channel (par 36), rotating in a helix-like shape (par. 15, figs. 2d, 3b, 4), wherein dimensions of the side openings are of sizes designed to enable bone and bone tissue ingrowth into the hollow inner channel and bone and bone tissue outgrowth from the hollow inner channel to the surrounding bone (see abstract, par. 15). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the shape of the openings taught by Caterini with the helix like shape of Kim in order to allow for the desired bone ingrowth. It is noted that Caterini teaches the openings can be a variety of shapes including radial (see pg. 6, last full paragraph). Therefore the shape of the openings is taught as a design choice. Caterini/Kim teaches the invention as substantially claimed and discussed above, however, does not specifically the bone inducing agent is predisposed within the porous structure.
Lee teaches an implant having a porous structure defining a plurality of pores and wherein bone inducing agents are predisposed within the porous structure (see par. 24). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Caterini/Kim to include bone inducing agents within the porous structure as taught by Lee in order to promote bone formation.
With respect to claim 97 Caterini/Kim/Lee teaches the invention as substantially claimed and discussed above, Caterini further teaches an abutment 3, however, does not specifically teach the abutment is a screw. Kim further teaches wherein the threaded implant further comprising a plug-in screw, a healing cap screw, or an abutment screw removably couplable with the open ceiling, extending into the hollow inner channel (pars. 18, 44, claim 5). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the abutment of Caterini with the threaded abutment as taught by Kim in order to easily attach and remove the abutment as needed.
With respect to claim 99, Caterini/Kim/Lee teaches the invention as substantially claimed and discussed above, Kim further teaches the threaded implant wherein the lower portion comprises one or more self-tapping cuts at a front end of the lower portion (par. 17). It would have been obvious to one having ordinary skill in the art to modify the implant of Caterini to include self-tapping threads as taught by Kim in order to easily install the implant such that the threads do not need to be tapped in an additional step.
With respect to claim 100, Caterini/Kim/Lee teaches the invention as substantially claimed and discussed above, Lee further teaches wherein the one or more injectable bone inducing agents include bone morphogenetic proteins (see par. 27). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Caterini/Kim to include bone inducing agents within the porous structure as taught by Lee in order to promote bone formation.
With respect to claim 103, Caterini/Kim/Lee teaches the invention as substantially claimed and disclosed above, Kim further teaches wherein the one or more side openings rotate in a helix-like shape in an opposite direction as that of a plurality of turns of the external thread (see fig. 1). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the shape of the openings taught by Caterini with the helix like shape of Kim in order to allow for the desired bone ingrowth.
Claim(s) 70 is/are rejected under 35 U.S.C. 103 as being unpatentable over Caterini (WO 01/05325) in view of Han et al. (2018/034435) in view of Lee (KR 20130042441) as applied to claim 69 above, further in view of Chang (WO 2019/240478).
With respect to claim 70, Caterini/Han/Lee teaches the invention as substantially claimed and discussed above, however, does not specifically teach the porous structure is biodegradable in vivo.
Chang teaches a threaded implant comprising an implant body 6 having an external thread 7 on an external surface of the implant body, the implant body comprising a middle portion defining a hollow inner channel (occupied by element 100), wherein the middle portion defines one or more side openings 9 extending from the hollow inner channel, wherein dimensions of the one or more side openings are of sizes designed to enable bone and bone tissue ingrowth into the hollow inner channel and bone and bone tissue outgrowth form the hollow inner channel to the surrounding bone (par. 62), wherein a structure 100 is disposed within the hollow inner channel. Chang further teaches with respect to claim 2, wherein the structure is biodegradable (pars. 27, 50, 57). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the porous member taught by Caterini/Han/Lee to be biodegradable as taught by Chang in order to maximize osseointegration area between the fixture and bone (par. 1, 15 of translation).
Claim(s) 70 is/are rejected under 35 U.S.C. 103 as being unpatentable over Caterini (WO 01/05325) in view of Kim (2015/0230889) in view of Lee (KR 20130042441).as applied to claim 69 above, further in view of Chang (WO 2019/240478).
With respect to claim 70, Caterini/Kim/Lee teaches the invention as substantially claimed and discussed above, however, does not specifically teach the porous structure is biodegradable in vivo.
Chang teaches a threaded implant comprising an implant body 6 having an external thread 7 on an external surface of the implant body, the implant body comprising a middle portion defining a hollow inner channel (occupied by element 100), wherein the middle portion defines one or more side openings 9 extending from the hollow inner channel, wherein dimensions of the one or more side openings are of sizes designed to enable bone and bone tissue ingrowth into the hollow inner channel and bone and bone tissue outgrowth form the hollow inner channel to the surrounding bone (par. 62), wherein a structure 100 is disposed within the hollow inner channel. Chang further teaches with respect to claim 2, wherein the structure is biodegradable (pars. 27, 50, 57). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the porous member taught by Caterini/Kim/Lee to be biodegradable as taught by Chang in order to maximize osseointegration area between the fixture and bone (par. 1, 15 of translation).
Response to Arguments
Applicant’s arguments with respect to claim(s) 2, 35-36, 62-65, 68-71, 97, 99-100 and 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed December 12, 2025 have been fully considered but they are not persuasive.
The applicant argues with respect to claim 1 (original claims 1 and 2) that Russell does not teach the porous structure as claimed. The applicant argues that Russell discloses the bone screw to allow for the passage of bone cement and that the internal plug is placed in the channel and it “may fully or partially block passage of a flowable medium distal to internal plug 12”. It is noted that Russell teaches an embodiment in which the plug is designed to be solid and block passages, however, it is noted that the embodiment of the plug being solid is NOT being used in the rejection above and therefore, the applicant’s arguments directed towards the plug completely blocking the flow are moot.
It is noted that as discussed above in detail and in the previous office action, the prior art of Russell teaches an embodiment in which the plug is porous and is used to varying the amount of flowable fluid being delivered to the channels. Specifically in par. 99 of Russell teaches the plug “may be substantially porous or hollow (FIGS. 4B and 4C), thereby allowing varying amounts of flowable material to flow through it to reach delivery channels 5 distal to the internal plug 12.” Therefore, the prior art of Russell teaches the claimed limitations requiring a porous structure (i.e. the plug being disclosed as being substantially porous) being disposed in the hollow inner channel, the porous structure defining a plurality of pores, as it is disclosed as being porous, therefore, it has pores, and the process in fluid communication with side openings, such that it controls the flow of the fluid to the openings.
The applicant further argues that the prior art of Russell does not teach the porous structure as claimed, but rather it teaches a hollow structure. While it is noted that Russell teaches an embodiment in which the plug element can be hollow (par. 99, specifically “porous or hollow”), that embodiment is NOT being used in the rejection above and therefore the arguments directed towards the hollow structure are moot. It is noted that porous is defined as “possessing or full of pores” therefore, the disclosed porous structure taught by Russell would have a plurality of pores by the nature of it being porous as disclosed.
The applicant further argues that the prior art of Russell discloses the function of their invention in that the plug is solid and blocks subsets of delivery channels. While it is noted that Russell does disclose and embodiment in which the plug is solid to block delivery channels, that embodiment is NOT being used in the rejection above. Russell also teaches a different embodiment in which the plug is disclosed as being porous and it can vary the amount of flowable fluid being delivered to the channels (see par. 99 and detailed discussion above). Therefore, the applicant’s arguments are not persuasive regarding the disclosed functioning of Russell being different than that of the claimed invention.
The applicant further argues that modifying Russell to have an internal plug to be porous would destroy the function and principle operation of the internal plug of Russell. However, it is noted that Russell teaches a porous plug (see detail arguments above) and the plug is NOT being modified to be porous. Further it is noted that several embodiments are disclosed including the one used in the rejection in which the plug is used to can vary the amount of flowable fluid being delivered to the channels (see par. 99 and detailed arguments above). Therefore, the principle operation and function of Russell is not being destroyed as the embodiment in which the plug is solid and blocking channels is NOT being used in the rejection or being modified in any way to teach the porous plug. The embodiment of the porous plug to varying the amount of flowable fluid to the pores is being used as discussed above in detail.
The applicant further argues that the claimed porous structure provides at least one technical advantage of promoting bone cell migration and early-stage growth along the surface of the pores. However, it is noted that the applicant has not claimed this advantage and therefore, the arguments are moot. Further, just because the prior art teaches a different advantage does not mean that it does not teach the claimed invention. As discussed above in detail, the claimed limitations are taught by Han in view of Russell and the porous structure of Russell provides the advantage of varying the flow of the fluid to the pores. While the applicant’s porous structure may also provide the advantage of promoting bone cell migration as argued, it is noted that the advantages are not claimed and therefore the arguments are moot.
The applicant further argues that the modification of Han with Russell would destroy the main reference of Han since the modification would prevent bone growth either via direct blockage of growth pathways and/or by limiting the amount of bone growth agent that flows into and out of the channel and/or openings. However, the modification would not destroy the invention of Han. Such that the embodiment of the porous plug does not completely block the openings, but rather acts more like a filter and varies the amount of fluid as discussed above in detail. The controlling of the fluid does not prevent bone growth as argued by the applicant. It is noted that pars. 27-28 teach the fluid being a bone growth fluid for promoting bone growth. It is further noted that just because Russell does not disclose bone growth within the porous structure does not mean that it is not capable of allowing bone growth. It is noted that the applicant has claimed an apparatus and not method and therefore, the apparatus would only need to be capable of allowing bone growth as argued by the applicant. As discussed above in detail the modification of Han with Russell does not destroy the bone ingrowth teaching of Han and therefore, the applicant’s arguments are moot and the rejection is maintained.
It is noted that claim 2 has been rejected under a new combination of references as it contained a new limitation that was not considered in combination with that of original claims 1 and 2.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/HEIDI M EIDE/Primary Examiner, Art Unit 3772 2/4/2026